FDA 510(k)

Accula Flu A/Flu B Test

K号: K171641 · 2018-02-06

决定日期2018-02-06

产品代码OZE

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决定实质等同

器械摘要

Accula Flu A/Flu B Test is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2018-02-06 under 510(k) number K171641. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Accula Flu A/Flu B Test?

Accula Flu A/Flu B Test is a medical device that received FDA 510(k) clearance on 2018-02-06. The listed applicant is Mesa Biotech, Inc.. The 510(k) number is K171641.

When did Accula Flu A/Flu B Test receive FDA 510(k) clearance?

Accula Flu A/Flu B Test received FDA 510(k) clearance on 2018-02-06, under 510(k) number K171641.

Who is the listed applicant for Accula Flu A/Flu B Test?

The FDA 510(k) record lists Mesa Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accula Flu A/Flu B Test?

The FDA product code for Accula Flu A/Flu B Test is OZE.

列明Mesa Biotech, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K201269Accula Strep A Test K181443Accula RSV Test

相关器械（代码：OZE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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